A Coordinating Center may be responsible for overall data management, monitoring and communication among all sites, and general oversight of the conduct of a human subjects research project. A Coordinating Center may be designated either by a sponsor or by mutual agreement of the participating sites.
A JHM/Lead Site Principal Investigator (PI) wishing to act as the Coordinating Center PI for a multi-site research effort must submit an eIRB application for JHM IRB review and approval which describes the Coordinating Center functions and responsibilities. The PI may submit either of the following in eIRB:
- For studies in which there will be no subject enrollment at Hopkins – a specific Coordinating Center application and protocol that outline the responsibilities of the Center and the Coordinating PI must be submitted to the IRB for review and approval prior to initiating the Center’s functions.
- For studies in which there will be subjects enrolled at Hopkins – an application and protocol in which the JHM PI outlines the conduct of the research with participants at Hopkins must be submitted to the IRB for review and approval. In such cases, a specific Coordinating Center protocol may or may not be available as a separate protocol submission. If not, the Coordinating Center functions should be described in the protocol or as separate document in the same eIRB application. The separate document (e.g. protocol appendix) should be uploaded in the Supplemental Study Documents section [item 2.0] of the eIRB application. The IRB will review the application materials submitted to determine if the Coordinating Center functions are described in sufficient detail.
In either case, the JHM IRB will confirm that the following are addressed by the PI in the description of the coordinating center and its functions:
- Confirmation that the Coordinating Center PI has contact information for all sites;
- Confirmation that each participating center has on file an active FWA with OHRP;
- A method for assuring that all sites have the most current version of the protocol and that amendments to the protocol will be communicated to all sites;
- A plan for collection and management of data from all sites as applicable;
- A process for reporting and evaluating protocol events and deviations from participating sites;
For Single IRB studies, in addition to the above criteria, the following must also be addressed in the multi-site protocol:
- A plan for collection of annual enrollment data from all sites for submission with the continuing review (if applicable);
- A plan for how you will educate sites about applicable JHM policies including the JHM IRB’s prompt reporting requirements; and
- A description of how the Coordinating Center will monitor protocol events and deviations, and ensuring appropriate reporting to the JHM IRB